Research Progress

Clinical significance and Research Progress of Hepatitis B Virus Markers

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  • National Institutes for Food and Drug Control, NMPA Key Laboratory for Quality Research and Evaluation of Medical Devices, NMPA Key Laboratory for Quality Research and Evaluation of In Vitro Diagnostics, Beijing 100050, China

Received date: 2024-06-11

  Online published: 2024-10-30

Abstract

Hepatitis B is a contagious disease that poses a severe threat to human health, caused by the infection of the Hepatitis B Virus (HBV). HBV infection is a prevalent worldwide, resulting in significant public health issues. Currently, with the administration of vaccines, and the treatment of antiviral drugs, the infection rate of HBV has been reduced. However, the eradication of HBV remains a major challenge. HBV markers are the primary indicators for diagnosing HBV infection, monitoring the progression of the disease, and evaluating the efficacy of antiviral treatment. Clinically, HBV markers mainly include traditional serological markers, virological markers, and new markers. In recent years, new markers have been developed which can more accurately evaluate the activity of HBV infection and the efficacy of antiviral therapy, and are of great value in monitoring the treatment of chronic hepatitis B. In this paper, the clinical significance and research progress of HBV markers, especially new markers, are reviewed, in order to provide references for accurate diagnosis, treatment and clinical prognosis of HBV.

Cite this article

Hao Xiaotian, Zhou Haiwei . Clinical significance and Research Progress of Hepatitis B Virus Markers[J]. Chinese Pharmaceutical Affairs, 2024 , 38(9) : 1086 -1092 . DOI: 10.16153/j.1002-7777.20240471

References

[1] 宋金云,王建芳,赵宏宇. 慢性乙型肝炎和肝硬化患者血清HBV基因型分析[J]. 实用肝脏病杂志,2021,24(1):87-90.
[2] 贺锐,刘实. 宿主因子参与HBV cccDNA形成和转录[J].科学通报,2019,64(30):3091-3100.
[3] 张向颖. 浅谈乙型肝炎病毒标志物[J]. 肝博士,2023(4):35-36.
[4] Tu T,Zhang H,Urban S.Hepatitis B Virus DNA Integration:In Vitro Models for Investigating Viral Pathogenesis and Persistence[J]. Viruses,2021,13(2):180.
[5] Kramvis A, Chang KM, Dandri M, et al.A Roadmap for Serum Biomarkers for Hepatitis B Virus: Current Status and Future Outlook[J]. Nat Rev Gastroenterol Hepatol,2022, 19(11):727-745.
[6] Global HIV, Hepatitis and Sexually Transmitted Infections Programmes. Global Progress Report on HIV, Viral Hepatitis and Sexually Transmitted Infections, 2021. Accountability for the Global Health Sector Strategies 2016-2021:Actions for Impact[C]. Geneva:WHO, 2022.
[7] 赵海,马晓华,吕娜,等. 西藏阿里地区人民医院就诊人群乙型肝炎病毒感染现状及其影响因素[J]. 中国感染控制杂志,2019,18(5):410-415.
[8] Zhang ZQ, Shi BS, Lu W, et al.Quantitative Serum HBV Markers in Predicting Phases of Natural History of Chronic HBV Infection[J]. J Virol Methods,2021,296:114226.
[9] 陈璐. 浅析化学发光法联合酶联免疫法在乙型肝炎病毒血清学检验中的应用效果比较[J]. 海峡药学,2021,33(3):154-156.
[10] Chevaliez S, Roudot-Thoraval F, Hézode C, et al.Performance of Rapid Diagnostic Tests for Hepatitis B Surface Antigen Detection in Serum or Plasma[J]. Diagn Microbiol Infect Dis,2021,100(2):115353.
[11] 中华医学会肝病学分会基础医学与实验诊断协作组. 乙型肝炎病毒标志物临床应用专家共识[J]. 中华肝脏病杂志,2023,31(4):389-400.
[12] 王馨,唐小琼,韩宁,等. 乙型肝炎病毒生物标志物的研究进展及其临床意义[J]. 生物医学工程学杂志,2023,40(6):1242-1248.
[13] 尤红, 王福生, 李太生, 等. 慢性乙型肝炎防治指南(2022年版)[J]. 实用肝脏病杂志, 2023, 26(3):457-478.
[14] 于德敏,张欣欣. 血清HBsAg定量检测在慢性乙型肝炎临床诊疗中的应用及其意义[J]. 临床肝胆病杂志,2019,35(10):2150-2155.
[15] Pondé RAA.Expression and Detection of Anti-HBs Antibodies after Hepatitis B Virus Infection or Vaccination in the Context of Protective Immunity[J]. Arch Virol, 2019,164(11):2645-2658.
[16] Jiang X, Chang L, Yan Y, et al.Paradoxical HBsAg and Anti-HBs Coexistence among Chronic HBV Infections: Causes and Consequences[J]. Int J Biol Sci,2021,17(4):1125-1137.
[17] 蔡兴龙. 乙肝患者血清HBeAg与HBV-DNA定量的相关性分析[J]. 河北医学,2019,25(5):820-823.
[18] 陈晓旭. 乙型肝炎病毒感染血清学标志物的检测及临床意义[J]. 实用预防医学, 2007(5):1637-1638.
[19] 郭艺飞,胡尧,蒋祺蓉,等. 乙型肝炎病毒e抗原定量检测的性能验证和临床应用探索[J]. 微生物与感染,2021,16(6):391-397.
[20] Pichoud C, Berby F, Stuyver L, et al.Persistence of Viral Replication after Anti-HBe Seroconversion during Antiviral Therapy for Chronic Hepatitis B[J]. J Hepatol,2000, 32:307-316.
[21] Wang Q, Klenerman P, Semmo N.Significance of Anti-HBc Alone Serological Status in Clinical Practice[J]. Lancet Gastroenterol Hepatol,2017,2(2):123-134.
[22] 陈翔宇,张海峰. 乙型肝炎病毒核心抗体定量检测研究进展[J]. 海南医学,2023,34(23):3492-3496.
[23] 蒋莹莹,郑素军. 乙型肝炎病毒新型标志物的临床意义解读[J]. 临床内科杂志,2020, 37(8):550-552.
[24] Zhang Z Q, Shi B S, Lu W, et al.Quantitative Anti-HBc in Liver Pathological States in Patients with Chronic Hepatitis B Virus Infection[J]. Can J Infect Dis Med Microbiol, 2019,2019:6545642.
[25] Wu Y, Wang X, Lin X, et al.Quantitative of Serum Hepatitis B Core Antibody Is a Potential Predictor of Recurrence after Interferon-Induced Hepatitis B Surface Antigen Clearance[J].J Microbiol Immunol Infection,2021,54(2):238-244.
[26] Fang Y Q, Xu X Y, Hou F Q, et al.A Baseline Model Including Quantitative Anti-HBc to Predict Response of Peg Interferon in HBeAg-Positive Chronic Hepatitis B Patients[J]. Antivir Ther,2021,26(6-8):126-133.
[27] Chi H,Li Z,Hansen BE,et al.Serum Level of Antibodies against Hepatitis B Core Protein Is Associated with Clinical Relapse after Discontinuation of Nucleos (t) ide Analogue Therapy[J]. Clin Gastroenterol Hepatol, 2019,17(1):182-191,e181.
[28] Li J, Gong Q M, Xie PL, et al.Prognostic Value of Anti-HBc Quantification in Hepatitis B Virus Related Acute-on- Chronic Liver Failure[J]. J Gastroenterol Hepatol,2021, 36(5):1291-1299.
[29] Tu T, Budzinska MA, Shackel NA, et al.HBV DNA Integration: Molecular Mechanisms and Clinical Implications[J]. Viruses,2017,9(4):75.
[30] Hou JL, Zhao W, Lee C, et al.Outcomes of Long-term Treatment of Chronic HBV Infection with Entecavir or Other Agents from a Randomized Trial in 24 Countries[J]. Clin Gastroenterol Hepatol,2020,18(2):457-467.
[31] Pujol F,Jaspe RC,Loureiro CL,et al. Hepatitis B Virus American Genotypes:Pathogenic Variants?[J]. Clin Res Hepatol Gastroenterol,2020,44(6):825,835.
[32] Wolf JM,Simon D,Lunge VR.Hepatitis B Virus Genotypes in Brazil: Introduction and Dissemination, Infection[J]. Infect Genet Evol,2021,93:104936.
[33] 刘娟娟,边中启.HBV相关肝病全基因组关联研究进展[J].国际病毒学杂志,2019,26(2):135-139.
[34] 李克坚,郝晓甜,周诚. 乙型肝炎病毒基因B型及基因C型两种国家标准品研制[J]. 分子诊断与治疗杂志,2024,16(1):113-117.
[35] 邱顺华,金李芬,张德文,等. 四川省自贡市159例慢性HBV感染者的HBV基因型分布及其与疾病进展关联研究[J]. 中国热带医学,2019(6):548-551.
[36] Lau KCK,Burak KW,Coffin CS.Impact of Hepatitis BVirus Genetic Variation , Integration , and Lymphotropism in Antiviral Treatment and Oncogenesis[J]. Microorganisms,2020,8(10):1470.
[37] Kaur SP,Talat A,Karimi-Sari H,et al.Hepatocellular Carcinoma in Hepatitis B Virus Infected Patients and the Role of Hepatitis B Surface Antigen(HBsAg)[J]. J Clin Med,2022,11(4):1126.
[38] 杜凌遥,马元吉,吕朵朵,等. 乙型肝炎病毒基因型及其临床意义的研究进展[J]. 肝脏,2021,26(9):1044-1046.
[39] Rajoriya N, Combet C, Zoulim F, et al.How Viral Genetic Variants and Genotypes Influence Disease and Treatment Outcome of Chronic Hepatitis B. Time for an Individualised Approach?[J]. J Hepatol, 2017, 67(6):1281-1297.
[40] Valdés JJ, Butterill PT, Růžek D.Flaviviridae Viruses Use a Common Molecular Mechanism to Escape Nucleoside Analogue Inhibitors[J].Biochem Biophys Res Commun, 2017,492(4):652-658.
[41] Carey I, Gersch J, Wang B, et al.Pregenomic HBV RNA and Hepatitis B Core-Related Antigen Predict Outcomes in Hepatitis B e Antigen-Negative Chronic Hepatitis B Patients Suppressed on Nucleos(t)ide Analogue Therapy[J]. Hepatology,2020,72(1):42-57.
[42] He P, Zhang P, Fang Y, et al.The Role of HBV cccDNA in Occult Hepatitis B Virus Infection[J]. Mol Cell Biochem, 2023,478(10):2297-2307.
[43] 唐红. HBV感染“新型”生物标志物的“前世今生”[J].临床肝胆病杂志,2019,35(10):2137-2139.
[44] 田原, 任峰. 乙型肝炎病毒共价闭合环状DNA(cccDNA)检测和清除的研究进展[J].中华微生物学和免疫学杂志,2019,39(11):875-879.
[45] Liao H, Liu Y, Li X, et al.Monitoring of Serum HBV RNA, HBcrAg, HBsAg and Anti-HBc Levels in Patients during Long-term Nucleoside/Nucleotide Analogue Therapy[J]. Antivir Ther,2019,24(2):105-115.
[46] Xia Y, Guo H.Hepatitis B Virus cccDNA: Formation, Regulation and Therapeutic Potential[J]. Antiviral Res, 2020,180:104824.
[47] 郝晓甜,李克坚, 周诚. 乙型肝炎病毒RNA检测试剂国家标准品的建立[J]. 中国病毒病杂志,2022,12(6):428-432.
[48] Lin N, Ye A, Lin J, et al.Diagnostic Value of Detection of Pregenerative RNA in Sera of Hepatitis B Virus-Infected Patients with Different Clinical Outcomes[J]. J Clin Microbiol,2020,58(2):e01275-19. doi:10.1128/ JCM.01275-19.
[49] Anderson M, Gerschj, Luk KC, et al.Circulating Pregenerative Hepatitis B Virus RNA Is Primarily Fulllength in Chronic Hepatitis B Patients Undergoing Nucleos(t)ide Analogue Therapy[J]. Clin Infect Dis, 2021,72(11):2029-2031.
[50] Liu S, Zhou B, Valdes JD, et al.Serum Hepatitis B Virus RNA: A New Potential Biomarker for Chronic Hepatitis B Virus Infection[J]. Hepatology, 2019,69(4):1816-1827.
[51] Jia W, Zhu MQ, Qi X, et al.Serum Hepatitis B Virus RNA Levels as a Predictor of HBeAg Seroconversion during Treatment with Peginterferon Alfa-2a[J].Virol J,2019, 16(1):61.
[52] Luo H, Zhang XX, Cao LH, et al.Serum Hepatitis B Virus RNA Is a Predictor of HBeAg Seroconversion and Virological Response with Entecavir Treatment in Chronic Hepatitis B Patients[J].World J Gastroenterol,2019,25(6):719-728.
[53] Bai L, Zhang X, Kozlowski M, et al.Extracellular Hepatitis B Virus RNAs Are Heterogeneous in Length and Circulate as Capsid-Antibody Complexes in Addition to Virions in Chronic Hepatitis B Patients[J]. J Virol,2018,92(24):e00798-18. doi: 10.1128/JVI.00798-18.
[54] 郝晓甜,刘艳,李克坚,等. 乙型肝炎病毒RNA检测试剂国家参考品的研制[J]. 中国药事,2023(4):396-403.
[55] Wu JW, Kao JH, Tseng TC.Three Heads Are Better than Two: Hepatitis B Core-Related Antigen as a New Predictor of Hepatitis B Virus-Related Hepatocellular Carcinoma[J]. Clin Mol Hepatol,2021,27(4):524-534.
[56] Inoue T, Tanaka Y.Novel Biomarkers for the Management of Chronic Hepatitis B[J]. Clin Mol Hepatol,2020,26(3):261-279.
[57] Liang L Y, Wong V W, Toyoda H, et al.Serum Hepatitis B Core Related Antigen Predicts Hepatocellular Carcinoma in Hepatitis B E Antigen-Negative Patients[J]. J Gastroenterol,2020,55(9):899-908.
[58] Hsu YC,Nguyen MH,Mo LR,et al.Combining Hepatitis B Core Related and Surface Antigens at End of Nucleos(t) ide Analogue Treatment to Predict Off-Therapy Relapse Risk[J]. Aliment Pharmacol Ther,2019,49(1):107-115.
[59] 陈恩强,唐红. 一种有前途的新型HBV血清标志物——HBcrAg[J]. 临床肝胆病杂志,2019,35(10):2159-2162.
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